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FDAFDA · Food and drugs·Recall number Z-0842-2024

1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

Published February 14, 2024 · Recall initiated: January 3, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Due to software and controller systems that results in unexpected pump start or pump stop.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Thoratec Corp.
Distributor
Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.
Lot
HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: DMPV40AAHP83 DMPVN1DFHP83 DMPVQ2JSHP51 DMPVQ374HP51 DMPVR6EXHP51 DMPVW1KDHP51 DMPW90USHP83 DMPWD118HP83 DMPWG096HP83 DMPWH036HP83 DMPWL02KHP83 DMPWL04QHP83 DMPWL05PHP83 DMPWL0AMHP83 DMPWL0T1HP83 DMPWL0XHHP83 DMPWL111HP83 DMPWL13CHP83 DMPWL14XHP83 DMPWL19RHP83 DMPWL1B7HP83 DMPWL1BPHP83 DMPWL1CCHP83 DMPWL1DVHP83 DMPWL21LHP83 DMPWL243HP83 DMPWL24PHP83 DMPWL29YHP83 DMPWL2BAHP83 DMPWL2DAHP83 DMPWM02VHP83 DMPWM0B5HP83 DMPWN01MHP83 DMPWN041HP83 DMPWN0A0HP83 DMPWN0AVHP83 DMPWN0XRJ28L DMPWR0AKHP83 DMPWR0AZHP83 DMPWR0BSHP83 DMPWR0C5HP83 DMPWR0CCHP83 DMPWR0DWHP83 DMPWR10BHP83 DMPWR11AHP83 DMPWR124HP83 DMPWR160HP83 DMPWR16ZHP83 DMPWR17CHP83 DMPWR17SHP83 DMPWR19BHP83 DMPWR19JHP83 DMPWR1D2HP83 DMPWR1DTHP83 DMPWR1F6HP83 DMPWR1MZHP83 DMPWT00PHP83 DMPWT02RHP83 DMPWT0CBHP83 DMPWT0NQHP83 DMPWT0PJHP83 DMPWT0URHP83 DMPWT0YHHP83 DMPWT118HP83 DMPWV09DHP83 DMPWV0BHHP51 DMPWV0C5HP83 DMPWV0C6HP83 DMPWV0CCHP83 DMPWV0CRHP83 DMPWV0DRHP83 DMPWV0DVHP83 DMPWV0E8HP83 DMPWV0EDHP83 DMPWV0FFHP83 DMPWV0FJHP83 DMPWV0FTHP83 DMPWV0GJHP83 DMPWV0GXHP83 DMPWV0H4HP83 DMPWV0H9HP83 DMPWV0J6HP83 DMPWV0JEHP83 DMPWV0JNHP83 DMPWV0K2HP83 DMPWV0K9HP83 DMPWV0LDHP83 DMPWW004HP83 DMPWW00KHP83 DMPWW00LHP83 DMPWW012HP83 DMPWW019HP83 DMPWW01BHP83 DMPWW04JHP83 DMPWW06PHP83 DMPWW095HP83 DMPWW0DKHP83 DMPWW0E9HP83 DMPWW0F1HP83 DMPWW0FGHP83 DMPWW0G7HP83 DMPWW0GAHP83 DMPWW0GBHP83 DMPWW0GLHP83 DMPWW0GWHP83 DMPWW0H0HP83 DMPWW0H1HP83 DMPWW0H7HP83 DMPWW0HLHP83 DMPWW0J7HP83 DMPWW0JGHP83 DMPWW0JZHP83 DMPWW0KDHP83 DMPWW0KKHP83 DMPWW0KWHP83 DMPWW0LCHP83 DMPWW0MCHP83 DMPWW0MKHP83 DMPWW0PWHP83 DMPWW0Q9J28L DMPWW0R5HP83 DMPWW0RGHP83 DMPWW0S5HP83 DMPX10UAHP51 DMPX10UDHP51 DMPX10ZMHP51 DMPX11Z2HP51 DMPX127EHP51 DMPX12GXHP51 DMPX12J0HP51 DMPX12JJHP51 DMPX12MKHP51 DMPX12RPHP51 DMPX12RRHP51 DMPX12S2HP51 DMPX12UPHP51 DMPX143YHP51 DMPX1AYLHP50 DMPX20FNHP83 DMPX20FPHP83 DMPX20G0HP83 DMPX20VNHP83 DMPX20VVHP83 DMPX20W2HP50 DMPX20ZRHP51 DMPX2141HP51 DMPX21A6HP83 DMPX21C8HP83 DMPX21LXHP83 DMPX21QAHP83 DMPX21TLHP51 DMPX228LHP50 DMPX22A2HP50 DMPX22B3HP50 DMPX22J4HP50 DMPX22WXHP51 DMPX2398HP51 DMPX3031HP83 DMPX304KHP83 DMPX305FHP83 DMPX30DEHP83 DMPX30E6HP83 DMPX30EDHP83 DMPX30EFHP83 DMPX30ELHP83 DMPX30FKHP83 DMPX30FPHP83 DMPX30FTHP83 DMPX30FWHP83 DMPX30G8HP83 DMPX30H8HP83 DMPX30H9HP83 DMPX30HBHP83 DMPX30HEHP83 DMPX30HGHP83 DMPX30J0HP83 DMPX30JHHP83 DMPX30JKHP83 DMPX30JNHP83 DMPX30JVHP83 DMPX30KCHP83 DMPX30KSHP83 DMPX30LXHP83 DMPX30M5HP83 DMPX30MHHP83 DMPX30MXHP83 DMPX30NCHP83 DMPX30NVHP83 DMPX30NXHP83 DMPX30P1HP83 DMPX30PFHP83 DMPX30PVHP83 DMPX30Q3HP83 DMPX30Q4HP83 DMPX30QQHP83 DMPX30RHHP83 DMPX30S3HP83 DMPX30SEHP83 DMPX30TMHP83 DMPX30TZHP83 DMPX30U7HP83 DMPX30USHP83 DMPX30UUHP83 DMPX30UYHP83 DMPX30VNHP83 DMPX30VRHP83 DMPX30WJHP83 DMPX30XXHP83 DMPX30YPHP83 DMPX30YSHP83 DMPX30Z3HP83 DMPX310WHP83 DMPX310YHP83 DMPX311MHP83 DMPX311SHP83 DMPX311VHP83 DMPX3126HP83 DMPX3127HP83 DMPX312GHP83 DMPX312QHP83 DMPX313CHP83 DMPX313MHP83 DMPX313NHP83 DMPX313UHP83 DMPX313YHP83 DMPX3148HP83 DMPX314LHP83 DMPX314NHP83 DMPX314SHP83 DMPX314WHP83 DMPX3152HP83 DMPX3158HP83 DMPX3159HP83 DMPX315BHP83 DMPX315KHP83 DMPX315QHP83 DMPX315XHP83 DMPX315YHP83 DMPX3169HP83 DMPX316HHP83 DMPX316MHP83 DMPX316XHP83 DMPX3172HP83 DMPX3177HP83 DMPX3179HP83 DMPX317MHP83 DMPX3180HP83 DMPX3186HP83 DMPX318CHP83 DMPX318FHP83 DMPX318QHP83 DMPX318UHP83 DMPX318YHP83 DMPX3195HP51 DMPX319BHP83 DMPX319CHP83 DMPX319VHP83 DMPX31AJHP83 DMPX31B4HP83 DMPX31CDHP83 DMPX31CWHP83 DMPX31D7HP51 DMPX31D8HP83 DMPX31DDHP83 DMPX31DVHP83 DMPX31EZHP83 DMPX31F7HP83 DMPX31F9HP83 DMPX31FDHP83 DMPX31FJHP83 DMPX31FKHP83 DMPX31GNHP83 DMPX31H4HP83 DMPX31X0HP51 DMPX31XZHP51 DMPX3238HP51 DMPX3459HP51 DMPX404VHP83 DMPX405UHP51 DMPX40AXHP83 DMPX41GLHP51 DMPX46T2HP50 DMPX470MHP50 DMPX50N3HP51 DMPX50P0HP50 DMPX50R3HP50 DMPX51E4HP51 DMPX51QLHP50 DMPX51RRHP50 DMPX51SVHP50 DMPX51V3HP50 DMPX51VKHP50 DMPX51ZAHP50 DMPX52NFHP51 DMPX52NPHP50 DMPX5310HP50 DMPX5357HP50 DMPX53J1HP50 DMPX53KZHP50 DMPX53WEHP
Risk classification
Class I
Area (FDA)
device
Country
United States

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